PIRAMAL SEVOFLURANE Sevoflurane liquid for inhalation 100% v/v bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sevoflurane, Quantity: 1 mL/mL

Available from:

Device Technologies Australia Pty Ltd

INN (International Name):

Sevoflurane

Pharmaceutical form:

Inhalation

Composition:

Excipient Ingredients:

Administration route:

Inhalation

Units in package:

1 x 250 mL bottle

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Piramal Sevoflurane may be used for induction and maintenance of general anaesthesia in adult and paediatric patients undergoing surgery.

Product summary:

Visual Identification: clear, colourless liquid; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2014-02-28

Patient Information leaflet

Piramal Sevoflurane™ CMI
Version 3 – 18 July 2014
Page
1 of 2
PIRAMAL SEVOFLURANE™
_SEVOFLURANE _
_ _
Liquid for inhalation, anaesthetic 100% v/v bottle CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some
common questions about Piramal
Sevoflurane™.
It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits
.
Your doctor has
weighed the risks of you taking
Piramal Sevoflurane™ against
the benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET. You may need
to read it again.
WHAT PIRAMAL
SEVOFLURANE
™ IS USED
FOR?
Piramal Sevoflurane™ belongs to
a group of medicines called
halogenated anaesthetic agents,
which are breathed in to induce
and/or maintain anaesthesia.
This medicine is administered by
an anaesthetist in the air you
breathe when you go for surgery. It
is a colourless liquid supplied in a
glass bottle. It is given by your
anaesthetist using a vaporiser,
which turns the liquid into a gas so
that you can breathe it in.
Piramal Sevoflurane™ is used for
inducing and maintaining heavy
sleep needed during surgery. The
medicine produces loss of
consciousness and pain
sensations during surgery.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU
.
BEFORE YOU RECEIVE
PIRAMAL SEVOFLURANE
™
_BEFORE YOU ARE DUE TO _
_RECEIVE PIRAMAL _
_SEVOFLURANE_
™
YOU MUST TELL YOUR DOCTOR IF:
1. YOU HAVE PREVIOUSLY HAD
ANY PROBLEMS WITH A GENERAL
ANAESTHETIC.
2. YOU OR ANYONE IN YOUR
FAMILY HAS MALIGNANT
HYPERTHERMIA (A RARE TYPE OF
SEVERE FEVER).
3. YOU HAVE RECENTLY HAD ANY
OTHER GENERAL ANAESTHETIC, OR
HAD MORE THAN ONE GENERAL
ANAESTHETIC OVER A SHORT
PERIOD OF TIME
4. YOU HAVE HAD PIRAMAL
SEVOFLURANE™ BEFORE AND
EXPERIENCED AN ALLERGIC
REACTION.
5. YOU HAVE OR HAVE HAD THE
FOLLOWING MEDICAL
CONDITIONS:

Any problems with your
liver including hep

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
PIRAMAL SEVOFLURANE™ (SEVOFLURANE) INHALATION
Piramal Sevoflurane™ PI
Page 1 of 20
1.
NAME OF THE MEDICINE
Sevoflurane
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Piramal Sevoflurane
TM
inhalation contains sevoflurane 100%v/v.
Sevoflurane is a non-flammable and non-explosive liquid administered
by vaporisation. Not more
than 130ppm of water is present in Piramal Sevoflurane
TM
. No other additives or chemical stabilisers
are used. It is non-pungent.
3.
PHARMACEUTICAL FORM
Piramal Sevoflurane™ is an inhalation anaesthetic. Piramal
Sevoflurane
TM
is a clear, colourless,
stable liquid.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Piramal Sevoflurane™ may be used for induction and maintenance of
general anaesthesia in adult
and paediatric patients undergoing surgery.
4.2 DOSE AND METHOD OF ADMINISTRATION
The concentration of sevoflurane being delivered from a vaporiser
during anaesthesia should be
known. This may be accomplished by using a vaporiser calibrated
specifically for sevoflurane. Filling
occurs directly from the bottle with an integrated adaptor,
multi-component closure or, in the case of
the bottle without the integrated adaptor multi-component closure,
with the use of an appropriate
adaptor calibrated specifically to fit the sevoflurane vaporiser.
PREMEDICATION
Premedication should be selected according to the need of the
individual patient, and at the
discretion of the anaesthetist.
INDUCTION
Dosage should be individualised and titrated to the desired effect
according to the patient's age and
clinical
status. A
short
acting
barbiturate
or
other
intravenous
induction
agent
may
be
administered followed by inhalation of sevoflurane. Induction with
sevoflurane may be achieved in
oxygen or in combination with oxygen-nitrous oxide mixtures. In adults
inspired concentrations of
up to 5% sevoflurane usually produce surgical anaesthesia in less than
2 minutes. In children
inspired concentrations of up to 7% sevoflurane usually produce
surgical anaesthesia in less than